FDA.reportPublic FDA data

venlafaxine hydrochloride

Product NDC
68788-6806
11-digit product format
687886806
Labeler code
68788
Product ID
68788-6806_64565232-cf19-4134-b9e5-641ef291af47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090174
Marketing category
ANDA
Marketing start
2016-11-07
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
venlafaxine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313581

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
17db3736-056c-48b9-b0f4-00fccabb14e6Product name520251118
7be8b949-f2c0-bdd8-e89d-8af92c1b2eadProduct name920250224
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-6806-1venlafaxine hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1008
68788-6806-2venlafaxine hydrochloride20 in 1 BOTTLECAPSULE, EXTENDED RELEASE208
68788-6806-3venlafaxine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE308
68788-6806-6venlafaxine hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE608
68788-6806-8venlafaxine hydrochloride120 in 1 BOTTLECAPSULE, EXTENDED RELEASE1208
68788-6806-9venlafaxine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-6806-3EA - Each68788-6806c1982690-7efa-482b-9910-1397e6ce113712020-05-08
68788-6806-9EA - Each68788-680676f6bffe-9b9f-4e88-842f-2b78335760c112020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-6806VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 6 package rows20240830_de6e30f8-c8ef-4016-b228-0f188645347b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNde6e30f8-c8ef-4016-b228-0f188645347b8
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDde6e30f8-c8ef-4016-b228-0f188645347b8
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYde6e30f8-c8ef-4016-b228-0f188645347b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-6806-168788680601100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-6806-1) 2016-11-070000-00-00NoNoCurrent
68788-6806-26878868060220 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-6806-2) 2016-11-070000-00-00NoNoCurrent
68788-6806-36878868060330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-6806-3) 2016-11-070000-00-00NoNoCurrent
68788-6806-66878868060660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-6806-6) 2016-11-070000-00-00NoNoCurrent
68788-6806-868788680608120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-6806-8) 2016-11-070000-00-00NoNoCurrent
68788-6806-96878868060990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-6806-9) 2016-11-070000-00-00NoNoCurrent